Medical Devices: Page 5

  • Woman using a laptop to contact a medical professional about her health. She is siting at a table in a kitchen and is taking her blood pressure with a blood pressure gauge.
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    Remote patient monitoring in Medicare needs more oversight: OIG

    Regulators say Medicare needs more data and oversight to avoid fraud and misuse. Digital health advocates argue the service is still crucial for managing chronic conditions.

    By Emily Olsen • Sept. 27, 2024
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    Nuthawut Somsuk via Getty Images
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    Mendaera raises $73M to develop handheld robotics platform

    Fred Moll, founder of surgical robotics firms Intuitive Surgical and Auris Health, participated in in the financing round, along with previous Auris investors.

    By • Sept. 27, 2024
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    Sarah Silbiger via Getty Images
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    Trendline

    Medical device safety in spotlight after high profile recalls

    From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

    By MedTech Dive staff
  • Jeff Shuren stands in front of a podium.
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    Permission granted by Peyton Helbert / AAMI
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    Lawmakers call for investigation of former FDA device director

    The letter to the health department watchdog follows a New York Times report that raised concerns about Jeff Shuren’s potential conflicts of interest as head of the FDA’s device center.

    By • Sept. 26, 2024
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    Sarah Silbiger via Getty Images
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    FDA proposes reclassifying hepatitis B assays

    The FDA plans to move the assays from higher-risk class III devices to class II, making them eligible for the 510(k) pathway.

    By • Sept. 26, 2024
  • A person lays with their arm outstretched and an x-ray camera facing it.
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    Courtesy of Siemens Healthineers
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    Medtronic, Siemens Healthineers partner on spine surgery

    Siemens Healthineers will integrate its robotic X-ray imaging system with Medtronic’s spine surgery suite.

    By • Sept. 25, 2024
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    The image by Ramsey Cardy/Collision/Sportsfile is licensed under CC BY 2.0
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    Masimo CEO, founder Kiani resigns

    Michelle Brennan was named acting CEO of the patient monitoring company following Joe Kiani’s defeat in a proxy battle with an activist investor.

    By • Sept. 25, 2024
  • Ross Segan is shown in a headshot.
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    Permission granted by FDA
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    FDA names new head of medical device evaluation and quality

    Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.

    By • Sept. 24, 2024
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    magicmine via Getty Images
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    Recalled heart devices had limited clinical testing, study finds

    Just 30 of 157 heart devices with Class I recalls underwent premarket clinical testing, according to a study published in the Annals of Internal Medicine.

    By • Sept. 24, 2024
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    libre de droit via Getty Images
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    Route 92 Medical raises $50M to fund global sales of stroke devices

    The latest investment extends an earlier funding round, bringing the total raised to $82 million. Novo Holdings, the controlling shareholder of Novo Nordisk, joined returning investors.

    By • Sept. 24, 2024
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    Getty Images via Getty Images
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    Stryker adds devices to remove brain tumors, clots with Nico buy

    Nico sells devices for navigating through the brain, visualizing the organ, removing tumors and clots and collecting tissue.

    By • Sept. 23, 2024
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    Sarah Silbiger via Getty Images
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    FDA posts draft guidance on biocompatibility testing of devices

    To promote consistency and reliability in premarket submissions, the FDA shared approaches for device biocompatibility analysis.

    By • Sept. 23, 2024
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    Scott Olson/Getty Images via Getty Images
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    Deep Dive

    4 steps to minimize the threat of legacy medical devices

    Older medical devices with unsupported software pose cybersecurity threats that regulators and industry are struggling to solve. Here are four steps experts say can help mitigate risks.

    By • Sept. 23, 2024
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    Permission granted by Abbott Laboratories
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    Abbott ramps up Libre 3 production amid shortages

    Some people are facing delays in filling prescriptions for the glucose sensor. Abbott expects to resolve the problem soon.

    By • Sept. 20, 2024
  • Masimo CEO Joe Kiani stands before an audience at a January 2024 meeting of the Patient Safety Movement Foundation.
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    Courtesy of Patient Safety Movement Foundation
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    Masimo investor claims proxy war win as CEO Kiani fails to retain board seat

    Politan Capital Management said its candidates captured two board seats in Thursday’s shareholder vote, citing a preliminary analysis.

    By • Sept. 20, 2024
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    Stock Photo via Getty Images
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    Jury sides with Axonics in Medtronic patent dispute

    Meanwhile, Boston Scientific is still waiting for antitrust regulators to conclude their review of its proposal to buy Axonics, which was announced in January.

    By • Sept. 19, 2024
  • Masimo CEO Joe Kiani looks over the countryside
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    Courtesy of BusinessWire/Masimo
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    Masimo proxy fight nears end as shareholder vote looms

    Chairman and CEO Joe Kiani’s board seat is on the line at today's shareholder meeting.

    By • Sept. 19, 2024
  • An x-ray image of a person's pelvis shows a hip replacement on the left side.
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    ChooChin via Getty Images
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    Zimmer pulls hip implant off the market due to fracture risk

    The company plans to phase out use of its CPT Hip System by December, but the FDA is still concerned about implants in new patients.

    By • Sept. 18, 2024
  • Exterior view of a building with columns and a sign that says "Cook."
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    Courtesy of Cook Medical
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    Merit Medical inks $210M takeover of Cook’s lead management business

    Merit predicts the portfolio, which includes devices used in procedures to remove or replace heart rhythm device leads, will add $40 million a year to its sales.

    By • Sept. 18, 2024
  • A black reader is shown on top of a phone with a blood glucose reading.
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    Permission granted by Senseonics
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    Senseonics receives FDA clearance for one-year CGM

    Commercial partner Ascensia is in discussions with insulin pump manufacturers to create an automated insulin delivery system.

    By • Sept. 17, 2024
  • A man sits at a table using Synchron’s BCI platform to control Amazon's Alexa.
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    Courtesy of Synchron
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    Synchron connects brain-computer interface tech to Amazon Alexa

    The patient can use the implant to turn on lights, make video calls, play music and shows, read books and buy products online without using their hands or voice.

    By • Sept. 17, 2024
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    Sarah Silbiger via Getty Images
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    Smiths Medical recalls airway tubes over defect linked to more than 10 injuries

    Smiths has had seven Class I recalls, the most severe kind, so far in 2024.

    By • Sept. 16, 2024
  • Boxes on a store shelf say "Soothe XP," showing eye drops for dry eye therapy.
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    Scott Olson via Getty Images
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    Bausch + Lomb considers sale: FT

    Private equity could be “the most likely” buyer of the eye care business, analysts wrote.

    By • Sept. 16, 2024
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    Scott Olson via Getty Images
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    Apple wins FDA nod for hearing aid software for certain Airpods

    Apple is the first company to receive authorization for over-the-counter hearing aid software.

    By • Sept. 13, 2024
  • A rounded deivce that says "Accu-Chek" is in front of a phone showing a glucose prediction
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    Permission granted by Roche
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    Roche to launch new CGM in Europe in ‘coming weeks’

    Roche will roll out its Accu-Chek Smartguide in the Netherlands, Switzerland and Germany. The company hopes to stand out from competitors with features to predict hypoglycemia.

    By • Sept. 12, 2024
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    SS Innovations expects US OK for surgical robot in 2025

    The robot maker plans to conduct clinical trials for several indications, including abdominal, pelvic, thoracic and cardiac procedures.

    By • Sept. 12, 2024